Xigris1003: Safety and Dose Finding Study of Xigris in Hemodialysis Patients
Sponsor
George Washington University (Other)
Overall Status
Completed
CT.gov ID
NCT01227187
Collaborator
Eli Lilly and Company (Industry)
12
1
1
26
0.5
Study Details
Study Description
Brief Summary
The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%).
Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant.
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Dose Finding Study of Xigris (Drotrecogin Alfa Activated) as an Anti-coagulant in End Stage Renal Disease (ESRD) Patients Treated With Hemodialysis (HD)
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Xigris Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis. |
Drug: Drotrecogin alfa activated (Xigris)
We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be assessed at baseline,15,30,60,120 and 180 mins. Xigris dose will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains <65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Partial Thromboplastin Time (PTT) at 15 Minutes [PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.]
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
- Mean Partial Thromboplastin Time (PTT) at 30 Minutes [PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.]
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
- Mean Partial Thromboplastin Time (PTT) at 60 Minutes [PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.]
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
- Mean Partial Thromboplastin Time (PTT) at 120 Minutes [PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.]
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
- Mean Partial Thromboplastin Time (PTT) at 180 Minutes [PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.]
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18
-
Usually used heparin with HD
Exclusion Criteria:
-
Plt <100
-
Pregnancy
-
H/o bleeding diathesis
-
H/o CVA
-
Pt on Ticlid/plavix/warfarin
-
SBP >200
-
BASELINE PTT>50
-
INR>1.6
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The George Washington University Hospital | Washington | District of Columbia | United States | 20037 |
Sponsors and Collaborators
- George Washington University
- Eli Lilly and Company
Investigators
- Principal Investigator: Lakhmir S Chawla, MD, George Washington University
Study Documents (Full-Text)
None provided.More Information
Publications
- Bernard GR, Ely EW, Wright TJ, Fraiz J, Stasek JE Jr, Russell JA, Mayers I, Rosenfeld BA, Morris PE, Yan SB, Helterbrand JD. Safety and dose relationship of recombinant human activated protein C for coagulopathy in severe sepsis. Crit Care Med. 2001 Nov;29(11):2051-9.
- Bernard GR, Macias WL, Joyce DE, Williams MD, Bailey J, Vincent JL. Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis. Crit Care. 2003 Apr;7(2):155-63. Epub 2003 Feb 28. Review.
- Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 Mar 8;344(10):699-709.
- Bleyer AJ, Russell GB, Satko SG. Sudden and cardiac death rates in hemodialysis patients. Kidney Int. 1999 Apr;55(4):1553-9.
- Bologa RM, Levine DM, Parker TS, Cheigh JS, Serur D, Stenzel KH, Rubin AL. Interleukin-6 predicts hypoalbuminemia, hypocholesterolemia, and mortality in hemodialysis patients. Am J Kidney Dis. 1998 Jul;32(1):107-14.
- Causes of death. USRDS. United States Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S107-17.
- Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose of dialysis on morbidity and mortality. Am J Kidney Dis. 1994 May;23(5):661-9.
- Hakim RM, Held PJ, Stannard DC, Wolfe RA, Port FK, Daugirdas JT, Agodoa L. Effect of the dialysis membrane on mortality of chronic hemodialysis patients. Kidney Int. 1996 Aug;50(2):566-70.
- Held PJ, Port FK, Webb RL, Wolfe RA, Bloembergen WE, Turenne MN, Holzman E, Ojo AO, Young EW, Mauger EA, et al. Excerpts from United States Renal Data System 1995 Annual Data Report. Am J Kidney Dis. 1995 Oct;26(4 Suppl 2):S1-186.
- Held PJ, Port FK, Wolfe RA, Stannard DC, Carroll CE, Daugirdas JT, Bloembergen WE, Greer JW, Hakim RM. The dose of hemodialysis and patient mortality. Kidney Int. 1996 Aug;50(2):550-6.
- Kaysen GA. Biological basis of hypoalbuminemia in ESRD. J Am Soc Nephrol. 1998 Dec;9(12):2368-76. Review.
- Kaysen GA. C-reactive protein: a story half told. Semin Dial. 2000 May-Jun;13(3):143-6.
- Kaysen GA. Role of inflammation and its treatment in ESRD patients. Blood Purif. 2002;20(1):70-80. Review.
- Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH. Psychosocial factors, behavioral compliance and survival in urban hemodialysis patients. Kidney Int. 1998 Jul;54(1):245-54.
- Kimmel PL, Phillips TM, Simmens SJ, Peterson RA, Weihs KL, Alleyne S, Cruz I, Yanovski JA, Veis JH. Immunologic function and survival in hemodialysis patients. Kidney Int. 1998 Jul;54(1):236-44.
- Lowrie EG, Laird NM, Parker TF, Sargent JA. Effect of the hemodialysis prescription of patient morbidity: report from the National Cooperative Dialysis Study. N Engl J Med. 1981 Nov 12;305(20):1176-81.
- Lowrie EG, Lew NL. Death risk in hemodialysis patients: the predictive value of commonly measured variables and an evaluation of death rate differences between facilities. Am J Kidney Dis. 1990 May;15(5):458-82.
- Owen WF Jr, Lew NL, Liu Y, Lowrie EG, Lazarus JM. The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis. N Engl J Med. 1993 Sep 30;329(14):1001-6.
- Owen WF, Lowrie EG. C-reactive protein as an outcome predictor for maintenance hemodialysis patients. Kidney Int. 1998 Aug;54(2):627-36.
- Patient mortality and survival. USRDS. United State Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S86-106.
- Yeun JY, Levine RA, Mantadilok V, Kaysen GA. C-Reactive protein predicts all-cause and cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):469-76.
Responsible Party:
Mardi Gomberg -Maitland,
Professor,
George Washington University
ClinicalTrials.gov Identifier:
NCT01227187
Other Study ID Numbers:
- F1K-MC-1003
First Posted:
Oct 25, 2010
Last Update Posted:
Feb 3, 2022
Last Verified:
Nov 1, 2020
Keywords provided by Mardi Gomberg -Maitland,
Professor,
George Washington University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted on stable inpatient HD patients between October 2008 and September 2010. The study design was based on different possible dose levels of APC infusion: 12, 18, 24, 30 μg/kg/h. The initial starting dose of APC for the first patient was 12 μg/kg/h. When a study patient's PTT was <60 s, the starting dose for the next study patient was increased by 6. There were no patient's in the 30 μg/kg/h group with a PTT of <60 s |
|---|---|
| Pre-assignment Detail | Participants were evaluated for inclusion and exclusion criteria and immediately enrolled in the study. |
| Arm/Group Title | APC Initiation Dose of 12 μg/kg/h | APC Initiation Dose of 18 μg/kg/h | APC Initiation Dose of 24 μg/kg/h | APC Initiation Dose of 30 μg/kg/h |
|---|---|---|---|---|
| Arm/Group Description | Activated protein C initiation dose of 12 μg/kg/h for the first patient | Activated protein C initiation dose of 18 μg/kg/h | Activated protein C initiation dose of 24 μg/kg/h | Activated protein C initiation dose of 30 μg/kg/h |
| Period Title: Overall Study | ||||
| STARTED | 1 | 3 | 3 | 5 |
| COMPLETED | 1 | 3 | 3 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Infusion Rate of 12 mcg/kg/h | Infusion Rate of 18 mcg/kg/h | Infusion Rate of 24 mcg/kg/h | Infusion Rate of 30 mcg/kg/h | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||||
| Overall Participants | 1 | 3 | 3 | 5 | 12 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
38
(0)
|
46
(21.3)
|
48.7
(13.1)
|
53.2
(7.9)
|
49
(12.6)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
100%
|
1
33.3%
|
1
33.3%
|
1
20%
|
4
33.3%
|
| Male |
0
0%
|
2
66.7%
|
2
66.7%
|
4
80%
|
8
66.7%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| White |
0
0%
|
1
33.3%
|
0
0%
|
1
20%
|
2
16.7%
|
| Black |
1
100%
|
2
66.7%
|
3
100%
|
4
80%
|
10
83.3%
|
| Height (inches) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [inches] |
66
(0)
|
68.7
(2.9)
|
73.3
(5.1)
|
68.8
(4.1)
|
69.7
(4.2)
|
| Weight (kilograms) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kilograms] |
96
(00)
|
69.6
(17.6)
|
104.5
(12.6)
|
79.4
(29.8)
|
84.6
(29.7)
|
| Diabetes (Count of Participants) | |||||
| Count of Participants [Participants] |
0
0%
|
0
0%
|
3
100%
|
3
60%
|
6
50%
|
| Congestive heart failure (Count of Participants) | |||||
| Count of Participants [Participants] |
0
0%
|
0
0%
|
1
33.3%
|
2
40%
|
3
25%
|
| WBC (10^3/µL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [10^3/µL] |
6.0
(0)
|
5.9
(1.8)
|
8.1
(0.7)
|
6.4
(1.2)
|
6.7
(1.4)
|
| Red blood cells (million/mm^3) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [million/mm^3] |
3.6
(0)
|
2.7
(0.4)
|
3.4
(0.9)
|
3.2
(0.5)
|
3.1
(0.6)
|
| Hemoglobin (g/dL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [g/dL] |
9.9
(0)
|
7.2
(0.6)
|
9.9
(1.4)
|
9.0
(1.4)
|
9.0
(1.0)
|
| Hematocrit (Percentage of red blood cells in blood) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Percentage of red blood cells in blood] |
31.2
(0)
|
23.2
(2.5)
|
30.9
(4.0)
|
27.9
(3.6)
|
27.8
(3.6)
|
| Platelets (10^9 per liter) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [10^9 per liter] |
333
(0)
|
196.7
(113.7)
|
315
(82.3)
|
220.2
(84.5)
|
247.4
(95.5)
|
| BUN (mg/dL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mg/dL] |
26
(0)
|
36.3
(9.5)
|
47
(17.4)
|
53.2
(17.1)
|
45.2
(17.1)
|
| Creatinine (μmol/L) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [μmol/L] |
15
(0)
|
7.8
(1.1)
|
7.8
(0.5)
|
9.2
(3.6)
|
9.0
(3.0)
|
| Prothrombin time (seconds) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [seconds] |
13.2
(0)
|
14.6
(0.2)
|
14.2
(1.0)
|
13.1
(1.0)
|
13.8
(1.0)
|
| Partial thromboplastin time (Seconds) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Seconds] |
38.1
(0)
|
37.3
(4.3)
|
37.6
(1.3)
|
35.5
(6.1)
|
36.7
(4.3)
|
| International Normalized Ratio (Ratio) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Ratio] |
1.1
(0)
|
1.2
(0.1)
|
1.2
(0.2)
|
1.0
(0.1)
|
1.1
(0.1)
|
Outcome Measures
| Title | Mean Partial Thromboplastin Time (PTT) at 15 Minutes |
|---|---|
| Description | PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant. |
| Time Frame | PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h |
|---|---|---|---|---|
| Arm/Group Description | APC Initiation dose 12 μg/kg/h | APC Initiation dose 18 μg/kg/h | APC Initiation dose 24 μg/kg/h | APC Initiation dose 30 μg/kg/h |
| Measure Participants | 1 | 3 | 3 | 5 |
| Mean (Standard Deviation) [Seconds] |
38.4
(NA)
|
38.4
(4.6)
|
45.4
(5.1)
|
49.7
(12.0)
|
| Title | Mean Partial Thromboplastin Time (PTT) at 30 Minutes |
|---|---|
| Description | PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant. |
| Time Frame | PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h |
|---|---|---|---|---|
| Arm/Group Description | APC Initiation dose 12 μg/kg/h | APC Initiation dose 18 μg/kg/h | APC Initiation dose 24 μg/kg/h | APC Initiation dose 30 μg/kg/h |
| Measure Participants | 1 | 3 | 3 | 5 |
| Mean (Standard Deviation) [Seconds] |
36.2
(NA)
|
35.7
(3.4)
|
48.2
(8.8)
|
51.3
(12.0)
|
| Title | Mean Partial Thromboplastin Time (PTT) at 60 Minutes |
|---|---|
| Description | PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant. |
| Time Frame | PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h |
|---|---|---|---|---|
| Arm/Group Description | APC Initiation dose 12 μg/kg/h | APC Initiation dose 18 μg/kg/h | APC Initiation dose 24 μg/kg/h | APC Initiation dose 30 μg/kg/h |
| Measure Participants | 1 | 3 | 3 | 5 |
| Mean (Standard Deviation) [Seconds] |
39.8
(NA)
|
36.4
(1.4)
|
39.2
(8.0)
|
52.6
(16.1)
|
| Title | Mean Partial Thromboplastin Time (PTT) at 120 Minutes |
|---|---|
| Description | PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant. |
| Time Frame | PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h |
|---|---|---|---|---|
| Arm/Group Description | APC Initiation dose 12 μg/kg/h | APC Initiation dose 18 μg/kg/h | APC Initiation dose 24 μg/kg/h | APC Initiation dose 30 μg/kg/h |
| Measure Participants | 1 | 3 | 3 | 4 |
| Mean (Standard Deviation) [Seconds] |
39.4
(NA)
|
42.8
(4.6)
|
51.2
(7.8)
|
54.1
(14.2)
|
| Title | Mean Partial Thromboplastin Time (PTT) at 180 Minutes |
|---|---|
| Description | PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant. |
| Time Frame | PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h |
|---|---|---|---|---|
| Arm/Group Description | APC Initiation dose 12 μg/kg/h | APC Initiation dose 18 μg/kg/h | APC Initiation dose 24 μg/kg/h | APC Initiation dose 30 μg/kg/h |
| Measure Participants | 1 | 3 | 3 | 4 |
| Mean (Standard Deviation) [Seconds] |
35.6
(NA)
|
40.9
(1.8)
|
44.5
(11.1)
|
52.4
(13.3)
|
Adverse Events
| Time Frame | Enrollment until post-treatment day 14 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h | ||||
| Arm/Group Description | APC initiation dose 12 μg/kg/h | APC initiation dose 18 μg/kg/h | APC initiation dose 24 μg/kg/h | APC initiation dose 30 μg/kg/h | ||||
All Cause Mortality |
||||||||
| APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | ||||
Serious Adverse Events |
||||||||
| APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/3 (0%) | 0/3 (0%) | 0/5 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| APC Initiation Dose 12 μg/kg/h | APC Initiation Dose 18 μg/kg/h | APC Initiation Dose 24 μg/kg/h | APC Initiation Dose 30 μg/kg/h | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | ||||
| Cardiac disorders | ||||||||
| Severe intradialytic hypertension | 0/1 (0%) | 0/3 (0%) | 0/3 (0%) | 1/5 (20%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Lakhmir Chawla |
|---|---|
| Organization | George Washington University |
| Phone | 202-715-4752 |
| lchawla@mfa.gwu.edu |
Responsible Party:
Mardi Gomberg -Maitland,
Professor,
George Washington University
ClinicalTrials.gov Identifier:
NCT01227187
Other Study ID Numbers:
- F1K-MC-1003
First Posted:
Oct 25, 2010
Last Update Posted:
Feb 3, 2022
Last Verified:
Nov 1, 2020